MedTrace Logo

Cluster Randomized Trial of a Digital Quality Improvement Intervention on LDLCholesterol Control

NCT05622929 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1465

Last updated 2026-04-14

No results posted yet for this study

Summary

Elevation in low density lipoprotein (LDL) cholesterol (LDL-C) is a causal risk factor for atherosclerotic established cardiovascular disease (ASCVD). Reduction of LDL-C with statins has been clearly demonstrated as a robust and cost-effective way of reducing the burden of ASCVD in individuals at risk. ASCVD is the leading cause of death and disability in Brazil and therefore prevention guidelines recommend LDL-C reduction with the aim of reducing disease burden in individuals at risk. Studies have shown a clear hiatus on awareness and treatment of cholesterol in Brazil. Thus, it became imperative to develop knowledge translation projects aiming at bridging the gap between science and clinical practice and ultimately leading to better outcomes. Cluster randomized clinical trials are the highest quality type of clinical research to test educational and active interventions aimed at changing behaviors or clinical practices. Therefore, this study is a pragmatic cluster randomized trial to assess the effect of a digitally enabled quality improvement intervention on LDL-C control in atherosclerotic established cardiovascular disease (ASCVD) patients.

Conditions

Interventions

BEHAVIORAL

Digitally-enabled Multifaceted Quality Improvement Intervention

Digitally-enabled multifaceted strategy in addition to access to a RWE platform to provide clinical data. The digitally-enabled multifaceted strategy will include various tools that will provide support to the health professionals responsible for treating ASCVD patients in each center as well as patients, including: * Knowledge of effective lipid lowering therapies * Clinical decision support * Audit and feedback on adherence to optimal clinical management * Audit and feedback on LDL-C control

BEHAVIORAL

Usual care

Health professionals responsible for treating ASCVD patients in each center will continue to provide usual care to ASCVD patients in addition to provide data through a RWE platform.

Sponsors & Collaborators

  • epHealth primary care solutions

    collaborator UNKNOWN

  • Novartis

    collaborator INDUSTRY

  • Hospital Israelita Albert Einstein

    lead OTHER

Principal Investigators

  • M. Julia Machline-Carrion, PhD · epHealth

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2025-08-15
Completion
2025-12-17

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05622929 on ClinicalTrials.gov